The ‘Fast-Track’ to Approval and Recall of Lotronex
The Dec. 11 issue of U.S. News & World Report takes a close look at the process that led drugmaker Glaxo Wellcome, Inc. to pull the irritable bowl syndrome drug Lotronex from the market on Nov. 28. Glaxo had hoped the drug would be a "blockbuster," bringing in millions of dollars a year while offering relief to the hundreds of thousands of women who suffer from irritable bowel syndrome. But while the drug "brought life-changing benefits" to some patients, it also has been linked to "severe side effects resulting in hospitalizations, surgeries and deaths." Now, U.S. News reports, Glaxo and the FDA "are on the defensive about their roles in the debacle" (Shapiro, U.S. News & World Report, 12/11).
Lotronex was approved using the FDA's "fast-track" approval process for "non-lifesaving" medications, which allows for a seven-month review instead of the standard one-year period. (California Healthline, 11/29.) According to U.S. News, despite early clinical trials that showed Lotronex could cause ischemic colitis and "exacerbate[d]" constipation, Glaxo orchestrated a push for approval, getting support from physicians, IBS sufferers and the International Foundation for Functional Gastrointestinal Disorders. The company mounted a "consciousness-raising" campaign for IBS, and underwrote an international meeting where physicians discussed and created the protocol for diagnosing IBS (U.S. News & World Report, 12/11). Members of Congress also lobbied the FDA for a speedy approval. Sen. Orrin Hatch (R-Utah), who had received $15,000 from Glaxo's PAC since 1998, wrote a letter urging the FDA to pass the drug. The FDA approved the drug on Feb. 9, but reconvened on June 27 to reconsider that approval, amid reports that linked its use several deaths, surgeries and hospitalizations. After discussions with Glaxo, the FDA agreed to continue allowing use of the drug, but required pharmacists to issue a "first-ever" medical guide with every prescription. Reported incidents of side effects "spike[d]," according to U.S. News, and the FDA "demanded" that Glaxo accept stricter controls of the drug. In response, Glaxo pulled the medication from the market on Nov. 28 (U.S. News, 12/11).
Women around the country "expressed their dismay" at Glaxo's decision last week (Krueger, Raleigh News & Observer, 11/30). Dr. Michael Elmore, an Indianapolis gastroenterologist, explained, "There's no other drug like this one. There's no substitute for it." He added, "These women have tried everything" (Barton, Indianapolis Star, 12/1). A Glaxo spokesperson said the firm received 350 to 400 calls an hour last Wednesday after the recall was announced. The deputy director of the FDA division that approved Lotronex said that the agency received "many" calls and emails disagreeing with the decision. Some have even tried to get Oprah Winfrey to examine the topic on her talk show (Raleigh News & Observer, 11/30).